Flexible annuloplasty prosthesis and holder

ABSTRACT

A valve repair system, preferably including an annuloplasty prosthesis and a holder for the prosthesis. The holder includes a first component having a central opening, a circumferential surface and an outwardly extending member. The annuloplasty prosthesis is located adjacent to the circumferential surface, above the outwardly extending member. The holder further includes a second component movable upwardly relative to the first holder component and includes a rigid penetrating member extending downward from the second component into the prosthesis, holding it adjacent the circumferential surface. The holder also includes a suturing guide for assisting a physician in valve repair surgery, which may be a cuttable suture extending across the central opening along a path approximating a desired line of leaflet coaption. The cuttable suture may additionally secure the first and second components to one another. The suturing guide may also be incorporated into one-piece annuloplasty prosthesis holders or into stand-alone tools that do not carry annuloplasty prostheses.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/174,199, filed Jun. 19, 2002 now U.S. Pat. No. 7,118,595 after “Jun.19, 2002”, which was a continuation-in-part of U.S. patent applicationSer. No. 10/100,444, filed Mar. 18, 2002, now U.S. Pat. No. 6,719,786.

BACKGROUND OF THE INVENTION

The present invention relates generally to surgical tools and moreparticularly for surgical tools used in conjunction with valve repair,including tools for holding prostheses such as annuloplasty rings andbands.

Annuloplasty rings and bands are useful in a variety of surgicalprocedures, including mitral and tricuspid annular reduction. In theseprocedures, sutures are first placed around all or portions of the valveannulus at spaced intervals. Sutures passing through the annulus inregions in which reduction of the valve annulus is desired are spacedequidistant from one another, for example, at 4 mm intervals. Thesesutures are then brought through the annuloplasty ring or band moreclosely spaced than where they pass through the annulus, for example, 2mm. The process of passing the sutures through the ring or band occurswhile the prosthesis is held above the valve annulus. The ring is thenmoved down into contact with the valve annulus, causing contraction ofthe annulus, thus effecting a reduction in valve annulus circumference.This basic procedure is used to correct both mitral and tricuspidannular dilatation.

In order for the sutures to be passed through the annuloplasty ring, itis desirable that the ring be held in a fixture or tool of some fashion.One early tool was manufactured by Pilling Instruments, and took thegeneral form of a cone provided with a circumferential groove near thebase. The cone was also provided with longitudinal slits, so that thetool could be contracted to accept the ring around the circumference ofthe groove. The tool was adapted to be held by means of a threadedhandle.

More recent holder designs are disclosed in U.S. Pat. No. 6,283,993,wherein sutures passing through the prosthesis are used to retain it ina circumferential groove on the holder. An alternative design isdisclosed in U.S. Pat. No. 5,011,481, which employs radially anddownwardly extending fingers in conjunction with sutures passing aroundthe prosthesis to retain it on the holder. Yet another alternativedesign is disclosed in U.S. Pat. No. 5,522,884, in which an adjustableannuloplasty ring is retained on its holder by tightening the adjustingsutures within the ring to contract it into a circumferential groove onthe holder.

Examples of flexible annuloplasty bands and rings are also disclosed inthe above cited patents, all of which are incorporated herein byreference in their entireties.

SUMMARY OF THE INVENTION

The present invention is directed toward an improved holder for use withannuloplasty prostheses. The holder is specifically configured to assistthe surgeon in performing the technique of mitral or tricuspidreduction, and is typically provided in conjunction with theannuloplasty ring or band, ready for use. The holder takes the generalform of an oblate ring component having an upper surface, a lowersurface, a central opening and an outer circumferential surfacecorresponding generally to the configuration of a valve annulus. Theprosthesis extends around at least a portion of this circumferentialsurface and is releasably retained alongside this surface during thepassing of sutures through the prosthesis.

The present invention provides improvements directed to the mechanismfor retaining the prosthesis on the holder during passage of the suturesand releasing the prosthesis after positioning on the valve annulus.Rather than retaining the annuloplasty ring to the holder by means ofsutures passing through the annuloplasty ring, the ring is retained bymeans of downwardly extending penetrating members such as barbs, pins,pegs, or needles, which enter the annuloplasty prosthesis and retain itto the holder during passage of sutures through the prosthesis. Thesepenetrating members may be fabricated of metal or molded plastic and aresufficiently rigid that they are not readily deflected outward to allowoutward movement of the annuloplasty prosthesis away from the holder.The penetrating members may have sharpened or relatively blunt tips.

The preferred embodiment is a two-component holder in which the firstcomponent includes the circumferential surface around which theprosthesis is mounted and the second component carries the penetratingmembers. The first component also typically includes radially extendingprojections that prevent the prosthesis from moving downward off of thepenetrating members, until upward movement of the second component. In apreferred embodiment, the first and second holder components areretained to one another, for example by means of a suture or suturescoupling the first and second components together. In this embodiment,the first and second components become movable relative to one anotherfollowing cutting of the suture or sutures retaining them together. Thefirst and second holder components are preferably molded of generallyrigid plastics but might in some cases be fabricated of metal or othermaterials.

The present invention generally is intended to provide a simplified andmore easily employed mechanism for holding the annuloplasty prosthesisduring passage of the sutures through the prosthesis and for releasingit from the holder after the ring has been moved downward into itsintended location on the valves annulus.

The holder of the present invention is also provided with a mechanismfor assisting the surgeon in the surgical repair of broken or elongatedchordae tendinae (chords), as is sometimes performed in conjunction withplacement of an annuloplasty prosthesis. This is accomplished by meansof a suturing guide extending across the central opening through theholder, approximating the line of leaflet coaption. Sutures used toreconnect the inner edges of the valve leaflets to the papillary musclesare knotted around the suturing guide and the leaflet edge, to assurethat the length of the suture is appropriate to allow leaflet coaption.

The suture guide may be any elongated structure, such a rod, bar orcord, but in the preferred embodiment of the invention, the suture guidetakes the form of a suture or sutures, extending across the openingthrough the holder. Cutting the suture allows it to be pulled throughthe knots at the leaflet edge, facilitating removal of the holder. Inthe disclosed embodiment, the suture or sutures extending across thecentral opening are extensions of sutures holding the first and secondcomponents closely adjacent one another, routed so that cutting thesutures to allow their removal from the knots at the leaflet edge alsoreleases the first and second components so that the second componentmay move upward relative to the first component, allowing removal of theannuloplasty prosthesis from the holder.

While in the preferred embodiments described below, the suture guide ispart of a two-component annuloplasty prosthesis holder, the suturingguide may also be incorporated in a one-piece holder or in a stand-alonetool which does not carry an annuloplasty prosthesis. In suchembodiments, the tool could include a single ring-shaped componentcorresponding generally to the annulus of the valve to be repaired andthe suturing guide could extend across the central opening through thering shaped component in a manner analogous to its location in thedisclosed preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a prior art annuloplasty prosthesis and holder, afterpassage of sutures through the annuloplasty prosthesis.

FIG. 2 illustrates a cross section through a prior art annuloplastyprosthesis holder.

FIG. 3 is a perspective view of a two-component annuloplasty prosthesisholder according and associated handle according to a preferredembodiment of the present invention.

FIG. 4 is a perspective view from above of the embodiment of FIG. 3,with the handle removed.

FIG. 5 is a perspective view from below of the embodiment of FIG. 3.

FIG. 6 is a perspective view from below of the embodiment of FIG. 3,illustrating the second component moved upwardly from the firstcomponent to release the annuloplasty prosthesis.

FIGS. 7A and 7B are a cross sectional views through portions of thefirst and second components of the embodiment of FIG. 3, illustratinginterconnection of the prosthesis and the holder components.

FIGS. 8A and 8B are cut-away views illustrating the use of the holder ofFIG. 3 in conjunction with a surgical repair procedure.

FIG. 9 is a perspective view of a second embodiment of two-componentannuloplasty prosthesis holder according and associated handle accordingto a preferred embodiment of the present invention.

FIG. 10 is a perspective view from below of the embodiment of FIG. 9.

FIG. 11 is a perspective view from below of the embodiment of FIG. 9,illustrating the second component moved upwardly from the firstcomponent to release the annuloplasty prosthesis.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a perspective view of a two-piece annuloplasty holderaccording to the prior art. In particular, the holder system asillustrated is described in the brochure “Medtronic Duran FlexibleAnnuloplasty Systems In Service Guide”, published by Medtronic, Inc. in2000, Publication No. UC200004685 EN, incorporated herein by referencein its entirety. The holder system includes a handle 16 which may bemade of metal or plastic, and which may, in some embodiments, include amalleable shaft allowing for manual reconfiguration of the shaft. Theshaft is snapped into the holder itself, which includes two components10 and 12 that are molded of rigid plastic. The upper component 10 ofthe holder is transparent and serves as a template, including markingsillustrating the locations of the valve trigones and regularly spacedmarkings assisting in placement of sutures around the annuloplastyprosthesis 13. As illustrated, the first component 12 of the prosthesisreleasably secured to the second component 10 of the prosthesis and theannuloplasty prosthesis 13 is mounted around a circumferential surfaceof the first holder component 12.

As illustrated, sutures 14 have been passed through the valve annulus 18and upwardly and outwardly through the prosthesis 13 itself, accordingto conventional practice for implantation of annuloplasty prostheses.The holder system is then used to move the prosthesis 13 downwardlyalong the sutures so that it is seated adjacent to the upper surface ofthe annulus 18. The second component 10 of the holder may be removedfrom the first component 12 by cutting the sutures holding themtogether, leaving the ring mounted around the first holder component 12,seated adjacent the valve annulus. Although not visible in this view,the first component 12 of the holder includes a large central orifice,so that testing to assure that leaflets of the heart valve co-apt can beaccomplished while the prosthesis 13 remains on the first component 12of the holder. In the particular product marketed by Medtronic, Inc.,removable of the prosthesis 13 from the first holder component 12 wasaccomplished by cutting sutures that held the prosthesis on the holder.

FIG. 2 is a cross section through the first and second components of theholder illustrated in FIG. 1, in conjunction with attached annuloplastyprosthesis 13. In this view it can be seen that the second component 10of the holder is provided with a formed recess 15 configured toreleasably engage a handle 16 (FIG. 1). In this view also it can be seenthat the first holder component 12 defines a large central apertureillustrated generally at 17, through which operation of the associatedheart valve can be observed after removal of the second holder component10. As noted above, component 10 is held to component 12 by means ofcuttable sutures, and prosthesis 13 is likewise maintained mounted tocomponent 12 by means of cuttable sutures. Mounting of the prosthesis 12to the first component 12 of the holder by means of these suturesrequires handwork, increasing the expense and complexity of productionof the system comprising the holder and the prosthesis. In addition,release of the prosthesis 13 from the first holder 12 requires multiplecuts of the sutures holding the prosthesis to the first holder component12, complicating the procedure for releasing the prosthesis from theholder.

FIG. 3 is a perspective view of a second embodiment of a two-pieceholder according to the present invention, with handle 209 attached. Inthis embodiment, annuloplasty prosthesis 204 is mounted against an outercircumferential surface of first holder component 202, which is in turnretained against second holder component 200. The second holdercomponent 20 is provided with a snap fitting 210, engaging a pin on theend of the handle 209. The snap fitting may be replaced by a threadedrecess or other mechanical mechanism for connecting to the handle 209.Snap fitting 210 is mounted to a removable base 211, which is retainedto cross bar 208 of component 200 by means of suture 213, which iscaptured to base 211. Handle 209 and base 211 are removed together aftercutting suture 213 at slot 215. Sutures 206 retain component 200adjacent component 202. Sutures 206 are tied to component 200 in thevicinity of grooves 207 and 205. When cut at grooves 207, component 200is released to move upward relative to component 202, in turn releasingthe annuloplasty prosthesis 204, as described in more detail below.

In this view it can seen that substantial apertures are defined throughthe assembly comprising components 200 and 202, allowing for testing ofthe coaption of valve leaflets. The portions of sutures 206 extendingacross the apertures, between the edges of component 200 and cross bar208 serve as a suturing guide to assist the physician in repair ofleaflets with damaged chordae tendinae, as discussed in more detail inconjunction with FIGS. 8A and 8B.

FIG. 4 is a perspective view from above of holder components 202 and 200and prosthesis 204 as illustrated in FIG. 3 showing removal of thehandle 209 and base 211 after cutting of suture 213. While the preferredembodiment as illustrated employs a relatively small base 211 to whichthe handle is mounted, in alternative embodiments a template asdiscussed in conjunction with FIGS. 1 and 2, held to component 200 bycuttable sutures, might be substituted for base 211. Alternatively, base211 might be omitted and snap fitting 210 might instead be formed aspart of the crossbar 208. In yet other alternative embodiments some orall of crossbar 208 might be replaced with an additional suturing guide.In some such embodiments, the snap fitting 210 might be mounted adjacentto the inner periphery of component 200.

FIG. 5 is a view from below of the first and second holder components202 and 200 in conjunction with the annuloplasty prosthesis 204.Numbered elements correspond to those in FIG. 3. In this view, therouting of the sutures 206 to retain first and second holder components202, 200 closely adjacent to one another is further illustrated. Sutures206 are tied to component 202 adjacent its outer periphery by knots 201,of which only one is visible. Free ends of sutures 206 then extendupward through component 200, across slots 207 (FIG. 3), back downwardthrough component 200, along L-shaped slots 221 and across the aperturesthrough component 202 to slot 229 in crossbar 208. Sutures 206 then passupward through crossbar 208, along slot 205 (FIG. 7) back downwardthrough crossbar 208 and are tied at knots 203 to retain them to thecrossbar.

In operation, the first and second components of the holder work asfollows. When first and second holder components 202, 200 are locatedclosely adjacent to one another as illustrated, pins 214 (not visible inthis view) extending downward from component 200 extend throughprosthesis 204. Projections 220 extend radially outward from the firstholder component 202 adjacent the lower surface of prosthesis 204preventing downward movement of the prosthesis off of pins 214. Thismechanical interrelation is illustrated in more detail in FIGS. 10 and11A, discussed below. When released, component 200 can move upwardlyenough to withdraw the pins 214 from prosthesis 204. Projections 220 areconfigured to allow them to bend inwardly after upward movement ofcomponent 200, facilitating removal of the prosthesis 204. Thismechanism is also discussed in more detail in conjunction with FIGS. 6and 7A. Holder components 200 and 202 are mechanically captured to oneanother by means of interacting tabs and grooves in regions 224 of theholder, described in more detail in conjunction with FIG. 7B.

FIG. 6 is a view from below of the first and second holder components202 and 200 in conjunction with the annuloplasty prosthesis 204.Numbered elements correspond to those in FIGS. 3-5. In this view,sutures 206 have been cut at slots 207, allowing for holder component200 to be moved slightly upwardly from holder component 202. Holdercomponent 200 has moved upwardly enough to withdraw pins 214 fromprosthesis 204. The prosthesis 204 is removed over projections 220,leaving it positioned adjacent to valve annulus. In this view, it can beseen that pins 214 extend through openings or interruptions 223 in thecircumferential flange 226 located adjacent the upper edge of component202. As illustrated in more detail in FIG. 7A, projections 220 can pivotinwardly, facilitating removal of the prosthesis 204 from the holderafter circumferential wall 228 of component 200 has moved upward of theprojections 220 and no longer prevents their inward motion.

In the specific embodiment illustrated, pins 214 extend all the waythrough the prosthesis 204 and into corresponding holes 221 in thelower, radially extending projections 220. In other embodiments, pins214 may be shortened and need not extend all the way to or into thelower radially extending projections 220. As discussed above, extensionof the pins 214 to or preferably into the projections 120 may beespecially desirable if the annuloplasty prosthesis 204 is very flexibleand or extensible and may be less beneficial if the annuloplastyprosthesis 204 is a generally rigid or inextensible prosthesis. Whilethe prosthesis 204 as illustrated takes the form of an annuloplastyring, the holder may also be used with a band. In such case, the pins214 are preferably located so that they will pass through the bandadjacent its ends.

FIG. 7A illustrates a cross-sectional view through a portion of thecombination of first holder component 200, second holder component 202and the prosthesis 204. In this view, illustrating the situation priorto upward movement of the second holder component. Pin 214 passesthrough the aperture 223 in the outwardly extending flange 226 (FIG. 6)of upper component 220, extends through prosthesis 204 and terminates inhole 221 in projection 220. Outwardly extending projection 220 preventsdownward movement of the prosthesis 204 off of pin 214. Preferably, thethickness of first component 200 is reduced at 219 to define a hingepoint, allowing projection 220 to pivot inward after upward movement ofcircumferential wall 228 has occurred.

FIG. 7B illustrates a cross-sectional view of a portion of the assemblycomprising first and second holder components 202, 200 and prosthesis204. This cross-section is taken through one of the regions 224illustrated in FIGS. 5 and 6. Holder components 200 and 202 are retainedto one another by projections or tabs 213 located slidably withingrooves 215, allowing upward movement of second component 200 until thelower end of 217 of groove 215 contacts the projection 213. Thismechanism limits upward movement of the second holder component 200 andretains first and second holder components 200, 202 together, asillustrated in FIG. 6.

FIGS. 8A and 8B are cut-away views illustrating the utility of sutures206 in conjunction with surgical repair of broken or elongated chordaetendinae (chords), as is sometimes performed in conjunction withplacement of an annuloplasty prosthesis. The basic procedure involved isdescribed in the article “Surgical Techniques For The Repair OfAnterior-Mitral Leaflet Prolapse” by Duran, published in the Journal OfCardiovascular Surgery, 1999; 14:471-481, incorporated herein byreference in its entirety. As illustrated in FIG. 8A, a double-armedsuture 252 is first attached to the papillary muscle 256 by means of apledget 258. Alternatively, as described in the Duran article, ifmultiple chords are to be replaced, a loop of suture may be attached tothe papillary muscle and multiple double-armed sutures passed throughthe loop for attachment to the valve leaflet or leaflets. Suture 252 isintended to replace the broken chord 255. The free ends of the suture252 are passed upward and sutured to the edge of valve leaflet 250,previously attached to the papillary muscle 256 by means of the brokenchord.

In the procedure as described in the above cited Duran article,adjustment of the height of the leaflet 250 to determine properplacement of knots 254, coupling the sutures 252 to the leaflet 250 wasaccomplished by means of an additional suture passed through theleaflet, held upward by means of forceps to adjust the appropriateleaflet height. In conjunction with the present invention, after theannuloplasty prosthesis 204 has been moved downward and sutured to thevalve annulus, suture 206 is used as a suturing guide for determiningthe proper point at which knots 254 are tied, to assure that the leaflet250 will coapt properly with the adjacent leaflet 251. Knots 254comprise a series of knots, the first of which is tied around suture206. The remaining knots are tied thereafter. One or more repairs ofthis type may be made along the portions of suture 206 extending acrossthe apertures through the annuloplasty prosthesis holder, depending uponthe number of chords that are broken. In the embodiment as illustratedin FIGS. 3-5 above, the path of the sutures 206 as they cross theapertures through the annuloplasty holder is intended to generallyapproximate the line of coaption of the leaflets of a mitral valve,facilitating their use in this particular surgery. Other possibleroutings for the sutures 206 might be substituted in conjunction withother possible valve repair surgeries.

FIG. 8B illustrates the production of knots 254 to anchor sutures 252 tothe valve leaflet 250 in more detail. In this view it can be seen thatone of the free ends of the suture 252 is passed upward through thevalve leaflet, around the edge of the valve leaflet and through theleaflet again, while the other free end is simply passed up through thevalve leaflet. The free ends are knotted together around suture 206 andthe series of knots is continued until an adequate number of knots areprovided to safely anchor the suture 252 to the valve leaflet 250.

After the leaflet repair is complete, sutures 206 are cut at slots 207(FIG. 3) as discussed above to allow annuloplasty holder component 200to move upward relative to component 202 (FIG. 6) to release theprosthesis 204. This also allows the cut ends of the sutures 206 to bepulled through the knot or knots 254, as the holder assembly is movedupward away from the valve annulus. While sutures 206, provide apreferred mechanism for facilitating the repair procedure discussedabove, it is possible that other structures could be substituted forthem, including other types of tensile members or more rigid memberssuch as rods or bars, provided that provision is made for removal of thestructures from the knots 254, after the surgical repair is complete.

FIG. 9 is a perspective view of an alternative embodiment of the presentinvention which operates in the same general manner as the embodimentillustrated in FIGS. 3-8B, described above. The embodiment of FIG. 9does include some differences in structure and function, which arediscussed in more detail below.

The handle 209A is somewhat modified from the handle illustrated in FIG.3, in that the lower end of the handle is provided with two inwardlydeflectable arms 209B, each carrying an outwardly extending projectionat their lower end, engaging in corresponding apertures 210B in snapfitting 210A. Base member 211A otherwise corresponds generally to basemember 211 discussed above, and is secured to holder component 200A bymeans of suture 215A in the same fashion as described in conjunctionwith base member 211 described above.

The suturing guide 206A takes the form of a cuttable suture, routed in amanner analogous to that of the above-described embodiment. However,cutting guides 207A are formed as grooves in the upper surface ofcomponent 200A rather than penetrating through the component. Further,two additional retention sutures 206B are provided, which operate toretain component 200A to component 202A, in addition to the retentionfunction performed by the sutures 206A. Sutures 206B are also associatedwith cutting guides 207A, which take the form of slots formed in theupper surface of component 200A. Cutting of the sutures 206A and 206B atall four of the cutting guides 207A is required in order for component202A to be moved downward relative to component 200A to release theprosthesis 204A, in a manner analogous to that described in conjunctionwith the embodiment discussed above.

FIG. 10 is a perspective view from the lower surface of the embodimentof FIG. 9. All numbered components correspond to identically numberedcomponents illustrated in FIG. 9, discussed above.

FIG. 11 is a perspective view from below the embodiment of FIG. 9 withcomponent 202A moved downward relative to component 200 to releaseprosthesis 204A. In order for component 200A to move downward relativeto component 200A, all of the sutures 206A and 206B must be cut atcutting guides 207A (FIG. 9).

In this view, the routing of sutures 206A and 206B is more clearlyillustrated. Sutures 206A are anchored to component 202A by passing themthrough two adjacent holes in component 202A and knotting the sutures at201A to retain them to component 202A. One end of each suture 206A isthen passed upward through adjacent holes the components 202A and 200A,extended across a cutting guide 207A (FIG. 9), passed downward throughadjacent holes in components 200A and 202A on the other side of cuttingguide 207A and passed through slot 221A. The sutures 206A are thenextended across the aperture through component 202A, where they areanchored to crossbar 208A by means of knot 203A in a manner identical tothat described in conjunction with the embodiment of FIGS. 3-8B. Sutures206B are first anchored to component 202A by being looped throughadjacent holes through component 202A and knotted at 201B. One free endof each suture 206B is then passed upward through adjacent holes incomponents 202A and 200A, extended across a cutting guide 207A (FIG. 9),passed downward through adjacent holes in components 200A and 202A onthe other side of cutting guide 207A and knotted at 201C to retaincomponents 200A and 202A adjacent to one another. As illustrated, thefree ends of the suture 206B are shown after cutting to allow downwardmovement of component 202A relative to component 200A.

In this view it can also be seen that the needles 214A, rather thanbeing provided with sharp tips as in the embodiment of FIGS. 3-8described above, are provided with rounded or ball-tip ends. The needles214A pass through prosthesis 204A and operate to retain the prosthesisto the holder in the same manner as described above in conjunction withthe embodiment of FIGS. 3-8B.

In conjunction with the above specification, we claim:

1. A method of repair of a heart valve comprising leaflets and a valveannulus, comprising: attaching a suture to a papillary muscle; placing asuturing guide across the valve along a desired line of leaflet coaptionusing an annuloplasty ring holder or ring-shaped component; knotting thesuture to the edge of one of the valve leaflets and around the suturingguide; and removing the suturing guide from the knot.
 2. A method as inclaim 1 wherein the placement of the suturing guide comprises placementof an annuloplasty prosthesis holder carrying the suturing guide.
 3. Amethod of repair of a heart valve comprising leaflets and a valveannulus, comprising: attaching a suture to a papillary muscle: placing asuturing guide across the valve along a desired line of leafletcoaption; knotting the suture to the edge of one of the valve leafletsand around the suturing guide; removing the suturing guide from theknot; and wherein the placement of the suturing guide comprisesplacement of a ring-shaped component carrying the suturing guide so thatthe suturing guide extends along the desired line of leaflet coaption.4. A method of repair of a heart valve comprising leaflets and a valveannulus, comprising: attaching a suture to a papillary muscle; placing asuturing guide across the valve along a desired line of leafletcoaption; knotting the suture to the edge of one of the valve leafletsand around the suturing guide; removing the suturing guide from theknot; and wherein the placement of the suturing guide comprisesplacement of a ring-shaped component having a central opening and havinga cuttable suture comprising the suturing guide extending across thecentral opening so that the suturing guide extends along the desiredline of leaflet coaption.
 5. A method as in claim 4 wherein the removalof the suturing guide comprises cutting the cuttable suture and pullingit through the knot.